Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

By | IP Intelligence | August 14, 2017
Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) must do when the applicant refuses discovery that the patent owner needs to determine whether it has a good faith basis for suit. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.  Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memoView Full Post
Tweet Like LinkedIn LinkedIn Google Plus

Mass Layoffs When Section 363 Sales Fail and Cases Convert: Third Circuit Adopts Probability Standard for WARN Act Liability

By | eSQUIRE Global Crossings | August 14, 2017
Mass Layoffs When Section 363 Sales Fail and Cases Convert: Third Circuit Adopts Probability Standard for WARN Act Liability On August 4, 2017, the Third Circuit Court of Appeals issued its ruling in Varela v. AE Liquidation, Inc. (In re AE Liquidation, Inc.), 2017 U.S. App. LEXIS 14359 (3d Cir. 2017), holding that WARN Act liability is triggered only when a mass layoff becomes probable – “that is, when the objective facts reflect that the layoff was more likely than not.” In doing so, the Third Circuit joined the Fifth, Sixth, Seventh, Eighth and Tenth Circuits, which have unanimously adopted this heighted standard as well. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

Do Your China Products Come from North Korea? What Will the Jury Say?

By | China Law Blog | August 14, 2017
Do Your China Products Come from North Korea? What Will the Jury Say? One of our China lawyers got a weird call a few weeks from a somewhat distraught clothing manufacturer who had just learned that products his company was having made in China may in fact have been made in North Korea. This person wanted to know whether if that were the case whether he might go to jail. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

And the Award for Most Oppressive Conduct by a Majority Shareholder Goes to . . .

By | New York Business Divorce | August 14, 2017
And the Award for Most Oppressive Conduct by a Majority Shareholder Goes to . . . Over the years I’ve litigated and observed countless cases of alleged oppression of minority shareholders by the majority. Oppression can take endlessly different forms, some more crude than others in their execution, some more draconian than others in their effect. If there was an award for the crudest and most draconian case of shareholder oppression, Matter of Twin Bay Village, Inc., 2017 NY Slip Op 06024 [3d Dept Aug. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

Lessons Learned from 2017 OCR HIPAA Enforcement Actions

Lessons Learned from 2017 OCR HIPAA Enforcement Actions So far 2017 is proving to be an active year for Health Insurance Portability and Accountability Act (HIPAA) enforcement. This comes on the heels of 2016, which saw an unprecedented level of enforcement actions, with 13 total settlements and nearly a 300 percent increase in total collected fines over 2015. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

SEQRA Permits Lead Agency to Remove Conditions from Conditional Declarations

SEQRA Permits Lead Agency to Remove Conditions from Conditional Declarations Petitioners, residents and nearby occupants (“Petitioners”), commenced a hybrid Article 78 proceeding and declaratory judgment action against the Planning Board of the Village of Tuckahoe (“Board”) and others in Murphy v. Planning Board of Tuckahoe (Sup. Ct. Westchester County 2017), to annul a negative declaration issued by the Board. View Full Post
Tweet Like LinkedIn LinkedIn Google Plus

GDPR-ready Contract Terms: Access Our Standard Templates

By | Israel Global Gateway | August 13, 2017
GDPR-ready Contract Terms: Access Our Standard Templates One of the larger tasks facing organizations as they prepare for the new EU General Data Protection Regulation is how to tackle data governance and compliance controls in the supply chain. This is often the Achilles heel for compliance risk, and the very prescriptive requirements of GDPR will require a thorough review of due diligence, contracting and ongoing contact management and audit practices.  View Full Post
Tweet Like LinkedIn LinkedIn Google Plus